WO2004100872A3 - Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin - Google Patents

Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin Download PDF

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Publication number
WO2004100872A3
WO2004100872A3 PCT/US2004/013758 US2004013758W WO2004100872A3 WO 2004100872 A3 WO2004100872 A3 WO 2004100872A3 US 2004013758 W US2004013758 W US 2004013758W WO 2004100872 A3 WO2004100872 A3 WO 2004100872A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
aerosol
generating
liquid
flow passage
Prior art date
Application number
PCT/US2004/013758
Other languages
French (fr)
Other versions
WO2004100872A2 (en
Inventor
Michael Hindle
Kenneth A Cox
Original Assignee
Chrysalis Tech Inc
Michael Hindle
Kenneth A Cox
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chrysalis Tech Inc, Michael Hindle, Kenneth A Cox filed Critical Chrysalis Tech Inc
Priority to JP2006532550A priority Critical patent/JP5054381B2/en
Priority to AU2004238235A priority patent/AU2004238235B2/en
Priority to EP04751246.2A priority patent/EP1626746B1/en
Priority to CA2524816A priority patent/CA2524816C/en
Publication of WO2004100872A2 publication Critical patent/WO2004100872A2/en
Publication of WO2004100872A3 publication Critical patent/WO2004100872A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/042—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008—Electronic counters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/02—Inhalators with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/02—Inhalators with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
    • A61M15/025—Bubble jet droplet ejection devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Diabetes (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Liquid aerosol formulations for generating aerosolized insulin include insulin and at least one high volatility carrier which protects the insulin from thermal degradation during vaporization of the carrier. The carrier can be a mixture of ethanol and water and the liquid aerosol formulation can be propellant free. An aerosol generating device generates the aerosolized insulin by passing the liquid aerosol formulation through a flow passage heated to convert the liquid into a vapor which entrains insulin particles which mix with air to form an aerosol. The insulin particles can be dry insulin particles produced by a hand held inhaler. By controlling the concentration of the insulin in the formulation, the size of the flow passage and/or the amount of heat which heats the flow passage, the aerosol can be provided with a selected mass median aerodynamic diameter of 1 to 3 µm or less than 1 µm so as to be delivered to a targeted portion of the lung using the inhaler.
PCT/US2004/013758 2003-05-07 2004-05-05 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin WO2004100872A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2006532550A JP5054381B2 (en) 2003-05-07 2004-05-05 Insulin-containing liquid aerosol formulation and aerosol generating device and method for generating aerosolized insulin
AU2004238235A AU2004238235B2 (en) 2003-05-07 2004-05-05 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin
EP04751246.2A EP1626746B1 (en) 2003-05-07 2004-05-05 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin
CA2524816A CA2524816C (en) 2003-05-07 2004-05-05 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US46826703P 2003-05-07 2003-05-07
US60/468,267 2003-05-07
US10/829,945 2004-04-23
US10/829,945 US7683029B2 (en) 2003-05-07 2004-04-23 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin

Publications (2)

Publication Number Publication Date
WO2004100872A2 WO2004100872A2 (en) 2004-11-25
WO2004100872A3 true WO2004100872A3 (en) 2005-12-29

Family

ID=33423716

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/013758 WO2004100872A2 (en) 2003-05-07 2004-05-05 Liquid aerosol formulations containing insulin and aerosol generating devices and methods for generating aerosolized insulin

Country Status (6)

Country Link
US (1) US7683029B2 (en)
EP (1) EP1626746B1 (en)
JP (1) JP5054381B2 (en)
AU (1) AU2004238235B2 (en)
CA (1) CA2524816C (en)
WO (1) WO2004100872A2 (en)

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Non-Patent Citations (1)

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Title
See also references of EP1626746A4 *

Also Published As

Publication number Publication date
US20040223917A1 (en) 2004-11-11
WO2004100872A2 (en) 2004-11-25
JP2007501271A (en) 2007-01-25
EP1626746B1 (en) 2016-12-07
EP1626746A4 (en) 2012-03-21
AU2004238235B2 (en) 2010-04-15
CA2524816A1 (en) 2004-11-25
JP5054381B2 (en) 2012-10-24
US7683029B2 (en) 2010-03-23
CA2524816C (en) 2017-06-20
AU2004238235A1 (en) 2004-11-25
EP1626746A2 (en) 2006-02-22

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